NDC 55111-137-79 - ZENATANE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55111-137
Requested NDC
55111-137-79
Package NDCs from labels
55111-137-79, 55111-137-81
Manufacturer
Dr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited FTO-SEZ-Process Unit-02 | Reed-Lane Inc.
Effective date
2026-09-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZENATANEDr. Reddy's Laboratories Limited | Dr. Reddy's Laboratories Limited FTO-SEZ-Process Unit-02 | Reed-Lane Inc.2026-09-20HUMAN PRESCRIPTION DRUG LABEL
Isotretinoin Capsules USPPhysicians Total Care, Inc.2014-08-22HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-05-02Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-137-79ZENATANE10 in 1 BLISTER PACKCAPSULE, GELATIN COATED1027
55111-137-81ZENATANE3 in 1 CARTONCAPSULE, GELATIN COATED327

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-137ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]27Current NDC, Legacy NDC, 2 package rows20250210_27b3cf26-f22e-5b70-1c24-009933b7c6ee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-137-79EA - Each55111-137f3f07928-fb93-467b-b8c8-58ed855cc51012013-05-02
55111-137-81EA - Each55111-137d63d0ccf-9941-42df-9ac4-d004648180d412013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
ISOTRETINOINACTIVE MOIETYEH28UP18IFZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
GELATININACTIVE INGREDIENT2G86QN327LZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918CZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
SHELLACINACTIVE INGREDIENT46N107B71OZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
SOYBEAN OILINACTIVE INGREDIENT241ATL177AZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [DR. REDDY'S LABORATORIES LIMITED]11
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
ISOTRETINOINACTIVE MOIETYEH28UP18IFZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
HYDROGENATED SOYBEAN OILINACTIVE INGREDIENTA2M91M918CZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
SOYBEAN OILINACTIVE INGREDIENT241ATL177AZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FZENATANE (ISOTRETINOIN) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 126 · 2,513 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-08-19WarningsExact identifier
unii: 5138Q19F1X
Absorica LDISOTRETINOINSun Pharmaceutical Industries, Inc.3ef0cff8-19c1-4441-b780-fca6c7ee16152026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Smelling SaltAMMONIAShenzhen Jufeng Qisheng Technology Co., Ltd.44e1b2c1-f524-782c-e063-6394a90ad1e42026-08-18WarningsExact identifier
unii: 5138Q19F1X
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
AmnesteemISOTRETINOINMylan Pharmaceuticals Inc.b2cb63c9-f825-4991-9a2c-6260f1bbcc2c2026-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.